Guidance on the Inventory of Select Agents and Toxins: Definitions for Regulated Select Agents and Toxins

The select agents and toxins lists can be found in 42 CFR § 73.3 (Health and Human Services (HHS) only agents), 42 CFR § 73.4 and 9 CFR § 121.4 (Overlap agents), 7 CFR § 331.3 (Plant Protection and Quarantine (PPQ) only agents), and 9 CFR § 121.3 (Veterinary Service only agents).

Accordingly, select agent infected materials, including confirmed clinical specimens, laboratory cultures, animals, animal tissues, plants, and plant tissues, are subject to regulation. Animals inoculated with toxins, however, are not regulated; only toxins or recombinant/synthetic nucleic acids encoding functional forms of the select toxins are regulated.

Inventory records are not required for select agent and toxin strains or constructs that FSAP has excluded from the provisions of the select agent regulations pursuant to 42 CFR § 73.3(e) (HHS only agents), 42 CFR § 73.4(e) and 9 CFR § 121.4(e) (Overlap agents), 7 CFR § 331.3(e) (PPQ only agents), and 9 CFR § 121.3(e) (VS only agents). Please see the Exclusion Guidance Document for more information. To apply for a novel exclusion, an entity must provide sufficient documentation that an attenuated select agent or modified toxin no longer poses a severe threat to the public health and safety, and/or animal health or animal products, or plant health or plant products, as appropriate. An entity does not need to apply for an exclusion if the agent is non-viable or the toxin is non-toxic as these are not regulated.

However, it is required that an entity maintain information on file in support of the method used for rendering a select agent non-viable or a select toxin non-toxic so that the entity is able to demonstrate that the agent or toxin is no longer subject to the select agent and toxin regulations.

Regulatory definitions that apply to this document

Biological Agent – Any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsia, or protozoa), or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing death, disease, or other biological malfunction in a human, an animal, a plant, or other living organism, deterioration of food, water, equipment, supplies, or material of any kind, deleterious alteration of the environment.

Toxin – Toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, or protozoa), or infectious substances, or recombinant or synthesized molecules, whatever their origin and method of production, and includes any poisonous substance or biological product that may be engineered as a result of biotechnology, produced by a living organism, or any poisonous isomer or biological product, homolog, or derivative of such a substance.

Recombinant Nucleic Acids – (1) Molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell or (2) molecules that result from the replication of those described in (1) above.

Synthetic Nucleic Acids – (1) Molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules or (2) or molecules that result from the replication of those described in (1) above.

Page last reviewed: December 16, 2020